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Enhancing Adherence by Building Online Communities

Primary Purpose

Type 2 Diabetes, Coronary Artery Disease, Obesity

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Stepping Up to Health
Sponsored by
Robert Wood Johnson Foundation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes focused on measuring heart, weight, Overweight, bmi, diabetes, type 2, diabetic, walk, walk*, diab*, obese, exercise, activity, coronary, pedometer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Must have one or more of the following: Coronary artery disease (CAD); BMI 25 or higher; Type 2 diabetes
  • Must be sedentary, defined by less than 150 minutes of self-reported activity per week
  • Must be 18 or older
  • Must have access to a computer with an Internet connection, a USB port, and Windows 2000 (latest service pack), XP or Vista
  • Must be a regular email user (checking weekly)
  • Must be able to communicate in English

Exclusion Criteria:

  • Pregnant
  • Cannot walk a block (self-report)
  • Not competent to sign consent
  • Unable to obtain medical clearance from a treating physician (primary care, cardiologist, endocrinologist)
  • Type 1 diabetes

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    1

    2

    Arm Description

    Stepping Up to Health only

    Stepping up to Health PLUS online message boards to talk with other participants

    Outcomes

    Primary Outcome Measures

    Total steps

    Secondary Outcome Measures

    dropout rate
    days and hours pedometer worn
    login frequency
    upload frequency
    content of posts (qualitative)

    Full Information

    First Posted
    August 1, 2008
    Last Updated
    January 27, 2009
    Sponsor
    Robert Wood Johnson Foundation
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00729040
    Brief Title
    Enhancing Adherence by Building Online Communities
    Official Title
    Enhancing Adherence to an Internet-Mediated Walking Program by Building Online Communities
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2009
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2008 (undefined)
    Primary Completion Date
    October 2008 (Actual)
    Study Completion Date
    January 2009 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Robert Wood Johnson Foundation

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of this study is to determine whether online peer support will increase adherence to an internet-based pedometer walking program.
    Detailed Description
    Stepping Up to Health with eCommunities is a study that takes what we already know about motivating sedentary, chronically ill people to walk, and begins to explore what it takes to keep people motivated to exercise over time: the ability to self-monitor behavior with accurate ecological momentary assessments. We have theorized that peer support, monitoring and competition are ways in which people can stay motivated to meet their walking goals; thus, we have built into this intervention online forums for participants to communicate with each other and garner support, as well as a pilot one-to-many competitive game based on the percent of an individual's goal met. Our research question is whether online community participation can increase adherence to an Internet-mediated walking program, which consists of an uploading pedometer, and going to a website to receive graphical and textual feedback as to whether participants are meeting gradually increasing walking goals. Three hundred participants will spend four months in this randomized, controlled trial to compare the intervention alone to the intervention plus online community support.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Type 2 Diabetes, Coronary Artery Disease, Obesity
    Keywords
    heart, weight, Overweight, bmi, diabetes, type 2, diabetic, walk, walk*, diab*, obese, exercise, activity, coronary, pedometer

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1, Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    324 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Active Comparator
    Arm Description
    Stepping Up to Health only
    Arm Title
    2
    Arm Type
    Experimental
    Arm Description
    Stepping up to Health PLUS online message boards to talk with other participants
    Intervention Type
    Behavioral
    Intervention Name(s)
    Stepping Up to Health
    Intervention Description
    Internet-mediated walking program with pedometers, goal-setting and tailored messaging
    Primary Outcome Measure Information:
    Title
    Total steps
    Time Frame
    last 30 days of intervention
    Secondary Outcome Measure Information:
    Title
    dropout rate
    Time Frame
    Four months
    Title
    days and hours pedometer worn
    Time Frame
    four months
    Title
    login frequency
    Time Frame
    four months
    Title
    upload frequency
    Time Frame
    four months
    Title
    content of posts (qualitative)
    Time Frame
    four months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Must have one or more of the following: Coronary artery disease (CAD); BMI 25 or higher; Type 2 diabetes Must be sedentary, defined by less than 150 minutes of self-reported activity per week Must be 18 or older Must have access to a computer with an Internet connection, a USB port, and Windows 2000 (latest service pack), XP or Vista Must be a regular email user (checking weekly) Must be able to communicate in English Exclusion Criteria: Pregnant Cannot walk a block (self-report) Not competent to sign consent Unable to obtain medical clearance from a treating physician (primary care, cardiologist, endocrinologist) Type 1 diabetes
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Caroline R Richardson, MD
    Organizational Affiliation
    University of Michigan Health System Dept. of Family Medicine
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    21169160
    Citation
    Richardson CR, Buis LR, Janney AW, Goodrich DE, Sen A, Hess ML, Mehari KS, Fortlage LA, Resnick PJ, Zikmund-Fisher BJ, Strecher VJ, Piette JD. An online community improves adherence in an internet-mediated walking program. Part 1: results of a randomized controlled trial. J Med Internet Res. 2010 Dec 17;12(4):e71. doi: 10.2196/jmir.1338.
    Results Reference
    derived
    PubMed Identifier
    19698154
    Citation
    Buis LR, Janney AW, Hess ML, Culver SA, Richardson CR. Barriers encountered during enrollment in an internet-mediated randomized controlled trial. Trials. 2009 Aug 23;10:76. doi: 10.1186/1745-6215-10-76.
    Results Reference
    derived

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